Quality Control Engineer II

Project overview

Exciting Senior Quality Engineer - Metrology opportunity with an established medical device manufacturing company.

Project details

12 Months

Required Skills & Experience

5+ years of Quality Engineering experience supporting metrology and calibration systems

2+ years of experience leading or supporting calibration/metrology remediation efforts in a regulated manufacturing environment

Strong knowledge of ISO 13485, 21 CFR Part 820/QMSR, ISO 17025, Gage R&R, and MSA methodologies

Expertise in dimensional metrology, calibration principles, measurement uncertainty, tolerance analysis, traceability, and guard banding

Experience conducting OOT/OOC investigations, impact assessments, CAPAs, risk assessments, and deviation management

Ability to analyze calibration data and equipment performance using risk-based decision-making methodologies

Experience supporting internal, customer, and regulatory audits

Proficiency with Minitab or similar statistical analysis tools

Desired Skills & Experience

Metrology experience in the medical device industry

Experience with CMMs, vision systems, automated assembly equipment, force/torque measurement, environmental monitoring, and packaging equipment

Familiarity with cleanroom environments and standards including ISO 9001, ISO 10012, and ANSI/NCSL Z540

Working knowledge of ProCal V5 and Siemens Teamcenter

Strong project management and cross-functional leadership skills

What You Will Be Doing

Tech Breakdown

Metrology / Calibration Program Remediation - 70%

Risk Assessment, Compliance, and Quality Systems Activities - 30%

Daily Responsibilities

Lead calibration program assessments and remediation initiatives

Perform gap analyses and develop sustainable remediation plans

Conduct OOT/OOC investigations and product impact assessments

Drive CAPA activities and quality system improvements

Author and revise calibration procedures, deviations, risk assessments, and impact assessments

Evaluate measurement systems, calibration intervals, traceability, and fitness-for-use decisions

Partner with Engineering, Manufacturing, Validation, Laboratory Operations, and Quality teams

Support internal, customer, and regulatory audits

Train stakeholders and implement long-term metrology process improvements

Job Facts: Contract W2 | On-site | $45 - $52/hr

Skills: Quality Control, Quality Assurance, ISO 13485, Management, Decision-making, Minitab, Statistics, Medical Devices, CMMS, Assembly, ISO 9000, Siemens, Teamcenter, Project Management, Leadership, Regulatory Compliance, Quality Management, Gap Analysis, Corrective And Preventive Action, Risk Assessment, Manufacturing, Auditing, Metrology, Process Improvement

Reference: Dice Id: 10105282 | Position Id: 893916

• Start: flexible
• Remote: onsite
• Location: Houston, TX, US, US